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Carlo Briguori, MD, PhD Interventional Cardiology Mediterranea Cardiocentro , Naples, Italy

REMEDIAL III REnal Insufficiency Following Contrast MEDIA Administration III TriaL Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration in high-risk patients for contrast-induced acute kidney injury. Carlo Briguori, MD, PhD Interventional Cardiology

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Carlo Briguori, MD, PhD Interventional Cardiology Mediterranea Cardiocentro , Naples, Italy

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  1. REMEDIAL III REnal Insufficiency Following Contrast MEDIA Administration III TriaLUrine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration in high-risk patients for contrast-induced acute kidney injury. Carlo Briguori, MD, PhD Interventional Cardiology MediterraneaCardiocentro, Naples, Italy

  2. Background • Hydration is the cornerstone in contrast-induced acute kidney injury (CI-AKI) prophylaxis1 • Tailored hydration regimens have been proposed to improve both efficacy and safety in the prevention of CI-AKI, such as • LVEDP-guided2 • Urine flow rate-guided3 1. McCullough PA. J Am CollCardiol 2008;51:1419-28 2. Brar S. et al. Lancet. 2014;383(9931):1814-1823 3. Briguori C, et al. Circulation. 2011;124(11):1260-1269.

  3. Purpose • We performed a multicenter, randomized, single-blind, phase 3, investigator-initiated trial comparing 2 tailored-hydration regimens: • LVEDP-guided hydration (LVEDP-guided group) • UFR-guided hydration (UFR-guided group) • The trial was registered with www.clinicaltrial.gov (NCT02489669) • In all cases iobitridol(Xenetix, Guerbet, Villepinte, France) a low-osmolar, non-ionic contrast agent) was administered. Guerbet provided an unrestricted grant to the MediterraneaCardiocentro.

  4. Study Population Between July 15, 2015 and June 6, 2019 Inclusion Criteria All consecutive patients with chronic kidney disease (CKD) an eGFR≤45 mL/min/1.73 m2 and/or At high risk for CI-AKI according to Mehran's score ≥11 and/or Gurm's score >7 • Exclusion Criteria: • Age <18 years • Women who are pregnant • Acute pulmonary edema • Acute myocardial infarction (STEMI) • Recent contrast media exposure • End-stage CKD on chronic dialysis • Multiple myeloma • Current enrolment in any other study when enrolment in the REMEDIAL III would involve deviation from either protocol • Cardiogenic shock • Administration of theophilline, dopamine, mannitol and fenoldopam

  5. Primary endpoint Composite of CI-AKI and/or acute pulmonary edema CI-AKI: increase in the serum creatinine concentration ≥25% and/or ≥0.5 mg/dLfrom baseline value at 48 hours after contrast media exposure Acute pulmonary edema: the sudden development of dyspnea and/or tachypnea and/or breathlessness associated with tachycardia, anxiety, cough and sweating after the initiation of the hydration regimen

  6. Secondary endpoints - Increase in the serum creatinine concentration ≥0.3 mg/dLat 48 hours - Changes in the serum cystatin C concentration at 24 and 48 hours - Rate of acute renal failure requiring dialysis - Rate of in-hospital, 1, 6 and 12-month major adverse events (MAE), including all-cause death, dialysis, acute pulmonary edema, and sustained kidney injury (defined as a persistent ≥25% GFR reduction compared to baseline at the last available value during the follow-up) - Length of in-hospital stay

  7. Sample size • Hypothesis: • Reduction in the primary endpoint from 9% in the LVEDP-guided group to 5% in the UFR-guided group • Sample size: • A total of 700 patients (350 each group) will be necessary to gave the study 80% power and a significance level <0.05

  8. Assessed for eligibility ( n = 933) Exclusion (n = 222) Not meeting inclusion/exclusioncriteria (n = 140) Refused to partecipate (n = 85) Enrollment Randomization (n = 708) LVEDPTDI assessment • Patientsallocated in the LVEDP-guidedgroup(n= 355) • Receivedallocated treatment (n = 351 ) • Didnotreceive the allocated treatment (n = 4) • Refused procedure (n = 3) • Fever ( n = 1) • Patientsallocated in the UFR-guidedgroup(n= 353) • Receivedallocated treatment (n = 351) • Didnotreceive the allocated treatment (n = 2) • RefusedFoleycatheter (n = 2 • Refused procedure (n = 0) Allocation Follow-up Patientslostat follow-up (n = 0) Patientslostat follow-up (n = 0) Patientsanalized (n = 355) Patientsexcluded from primaryendpointanalysis (n = 4) Patientsanalized (n = 353) Patientsexcluded from primaryendpointanalysis (n= 2) Analysis

  9. Clinical and biochemical characteristics

  10. Hydration volume Hydratation volume (ml)

  11. RenalGuard therapy phases Mean UFR was 416±158 mL/h Target UFR ≥300 mL/h was reached in 95% of patients. IntraproceduralUFR was ≥450 mL/h was reached in 228 (65%) patients. CM phase 104±48 min Post-CM phase 216±45 min Pre-CM phase 55±30 min Urine flow rate (mL/h) Time (minutes)

  12. B 4500 4500 4000 4000 3500 3500 ) ) L L 3000 3000 m m ( ( 2500 e 2500 e m m 2000 2000 u u l l o o 1500 1500 V V 1000 1000 500 500 0 0 15 45 75 105 135 165 195 225 255 285 315 345 375 15 45 75 105 135 165 195 225 255 285 315 345 375 Time ( minutes) Time ( minutes) Infusion/urine output balance Subgroup with LVEDP ≤12 mmHg Subgroup with LVEDP 13-18 mmHg Subgroup with LVEDP >18 mmHg 4000 3500 3000 ) L 2500 m ( e 2000 m u l 1500 o V 1000 500 0 15 45 75 105 135 165 195 225 255 285 315 345 375 Time ( minutes) Infusion Urine

  13. Side effects • Three patients in the UFR-guided group (0.8%) experienced complications related to Foley insertion, that is: • hematuria (n = 1) • pain on micturition (n = 2) • No patient had urinary tract infection • Hypokalemiaoccurred in 22 (6.2%) patients in the UFR-guided group and in 8 (2.3%) patients in the LVEDP-guided group (RR = 2.70; 95% CI 1.21-6.37; p = 0.013). Potassium replacement was necessary in 18 (5.1%) in the UFR-guided group and in 5 (1.4%) patients in the LVEDP-guided group (RR = 3.74; 95% CI = 1.37-10.13; p = 0.009) • Hypernatriemiawas observed in 1.2% of patients in the LVEDP-guided group and in 1.2% patient in the UFR-guided group (p = 1.00)

  14. Primaryendpoint NNT to prevent one event with the Renalguard therapy = 22 RR = 0 . 56 ( 0 . 39 - 0.79 . ) ; p = 0 . 036 12 10.3% 36/351 10 8 5.7% Primaryendpoint(%) 6 20/351 4 2 0 UFR-guidedgroup LVEDP-guidedgroup

  15. Primaryendpoint RR = 0.56 (95% CI = 0.39-0.79) p = 0.036 11 10% 10 35/351 9 8 7 5.7% 6 % 20/351 5 RR = 0.07 (95% CI = 0.02-1.16) p = 0.069 4 3 2% 2 7/351 1 0.3% 0 CI-AKI Pulmonary edema UFR-guidedgroup LVEDP-guidedgroup

  16. Primaryendpoint Pre-specified subgroups

  17. Characteristics of patients with acute pulmonary edema

  18. Secondary endpoints

  19. 1-month MAE

  20. Conclusions • UFR-guided approach (carried out by the RenalGuard system) is superior to the LVEDP-guided hydration regimen to prevent the composite of CI-AKI and/or acute pulmonary edema in high-risk patients. • A strict control of potassium balance is required during RenalGuard therapy.

  21. Mediterranea Cardiocentro, Naples C. Briguori A. Focaccio G. Visconti F. De Micco C. D’Amore P. Elia REMEDIAL III Investigators • Federico II Universityof Naples • G. Esposito • R. Piccolo • Multimedica IRCCS, Milan • F. Airoldi • D. Tavano • Policlinico di Bari, Bari • N. Signore • A. Dachille

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